Cooper Vision Caribbean
FDA inspection history across 2 sites, 2008 to 2014
- 1
- Close-out
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Close-out
- Warning letter
- Form 483
2008: one Form 483; 2014: one close-out letter and one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2008One Form 483, at Juana Diaz, Maryland.
- 2014One close-out letter and one warning letter, at Pleasanton, California.
Cited most
Across all Cooper Vision Caribbean observations on file
- 21 CFR 820.100Corrective and preventive action1
- 21 CFR 820.198Complaint files1
- 21 CFR 820.75Process validation1
The complete Cooper Vision Caribbean file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Pleasanton, California
One close-out letter and one warning letter · 2014
Latest: Close-out, Oct 20, 2014 →Juana Diaz, Maryland
One Form 483 · 2008 · 3 observations
Latest: Form 483, Apr 25, 2008 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2014-10-20 | Close-out Close-out letter | Pleasanton, California | — | $99 |
| 2014-02-27 | Warning letter Warning letter | Pleasanton, California | — | $99 |
| 2008-04-25 | 483 Form 483 | Juana Diaz, Maryland | 3 | $99 |
Investigators on these documents
FEI number 3002911336 · most recent document Oct 20, 2014
About Cooper Vision Caribbean
How many FDA Form 483s has Cooper Vision Caribbean received?
FDA Intel has 1 Form 483 on file for Cooper Vision Caribbean; the most recent is dated Apr 25, 2008.
When was Cooper Vision Caribbean last inspected by FDA?
The most recent FDA inspection document on file for Cooper Vision Caribbean is a Form 483 dated Apr 25, 2008, for the site in Juana Diaz, Maryland.
What did FDA cite at Cooper Vision Caribbean?
The regulations cited most in the observations on file for Cooper Vision Caribbean are 21 CFR 820.100 (Corrective and preventive action), 1 time; 21 CFR 820.198 (Complaint files), 1 time; 21 CFR 820.75 (Process validation), 1 time.
Has Cooper Vision Caribbean received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Cooper Vision Caribbean; the most recent is dated Feb 27, 2014.